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Key Developments & Implications of the European Health Data Space

In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a […]

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals 

The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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All About Software as a Medical Device (SaMD)

Understanding Software as a Medical Device (SaMD)

The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on general-purpose computing platforms, such as smartphones or

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Roadblocks in Global Pharmacovigilance Harmonization

Overcoming Roadblocks in Global Pharmacovigilance Harmonization

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to

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US FDA Radiological Health Regulations

Navigating US Regulations in Radiological Health 

Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure).  As we navigate through 2025, staying informed about

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Role of Blockchain and IoT in Drug Development.

Evaluating the Role of Blockchain and IoT in Drug Development

The pharmaceutical industry is undergoing a significant transformation, driven by the need for innovation and efficiency in pharmaceutical drug development. Drug development is a resource-intensive process that can take 10–15 years and cost billions of dollars to bring a medicine to market. One important aspect is the clinical trials, which face many challenges, including data

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South Koreas Regulatory Landscape for drugs

Navigating the Drug Regulatory Landscape of South Korea

With its rapidly growing pharmaceutical industry and stringent regulatory requirements, South Korea is becoming a key global player. But for pharmaceutical companies, navigating this landscape requires strategic planning and compliance expertise.  The Ministry of Food and Drug Safety in South Korea (MFDS), previously known as the Korean Food and Drug Administration, serves as South Korea’s

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pharmacovigilance approach for biosimilars market

Pharmacovigilance Approaches for Biosimilars Market Success 

The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing the cost of therapies. The complexities that even a slight manufacturing differences can lead to variations in protein structure, post-translational modifications, and glycosylation patterns. Since

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Global Cosmetic Regulations A Guide for Cometic Products

Understanding Global Cosmetic Regulatory Standards

The global cosmetic industry is a complex and rapidly growing landscape where regulatory compliance is fundamental in ensuring product safety, efficacy, and market access. As cosmetic products cross borders, manufacturers must comply with country-specific regulations from ingredients safety to product labeling. These regulations protect consumers and set the standards that businesses must follow to enter

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Outsourcing MAH

How Does Outsourcing MAH Responsibilities Impact a Pharmaceutical Company’s Global Expansion Strategy?

Marketing Authorisation Holder (MAH) refers to a person or company that has been granted permission to market a pharmaceutical product within a specific country. MAHs are subject to a number of regulatory requirements and ensure pharmaceutical products meet stringent safety and quality standards. As regulatory frameworks are becoming more stringent, many companies are turning to

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